The following data is part of a premarket notification filed by Genadyne Biotechnologies, Inc. with the FDA for Lucina-melodi.
| Device ID | K112856 |
| 510k Number | K112856 |
| Device Name: | LUCINA-MELODI |
| Classification | Pump, Breast, Powered |
| Applicant | GENADYNE BIOTECHNOLOGIES, INC. 16 MIDLAND AVE Hicksville, NY 11801 |
| Contact | Chien-ming Goh |
| Correspondent | Chien-ming Goh GENADYNE BIOTECHNOLOGIES, INC. 16 MIDLAND AVE Hicksville, NY 11801 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-30 |
| Decision Date | 2012-05-10 |
| Summary: | summary |